MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. ESPOCAN®; SPINAL EPIDURAL ANESTHESIA

Catalog Number	333192
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Although it was confirmed that the device is not available for further evaluation, the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: patient arrived to labor and deliver for c-section.Epidural catheter tip broke off during placement.The patient received an epidural catheter; catheter not believed to be in a functioning position.Upon removal, the catheter broke and 7.5 cm was retained.A neurosurgical consult did determine that no surgical intervention was required at this time.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned for evaluation.Further investigation of the complaint is not possible without a sample.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.While we are unable to confirm the reported defect, we will maintain this report for future reference, and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow-up will be submitted.

• Brand Name: ESPOCAN®
• Common Device Name: SPINAL EPIDURAL ANESTHESIA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8037444
• Report Number: 2523676-2018-00092
• Device Sequence Number: 1498902
• Product Code: OFT
• UDI-Device Identifier: 04046964179266
• UDI-Public: 04046964179266
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 333192
• Device Lot Number: 0061615216
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1